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Switzerland Overhauls Device Manufacturing Certificate Process
Devices Regulatory Affairs
Swiss Medic will overhaul the way it issues export certificates and manufacturing certificates for devices in the fall and introduce new fees that take effect on Jan. 1.
Export certificates and manufacturing certificates are issued for countries that don’t recognize European CE marking and the increased demand was becoming unsustainable, the agency said.
Upcoming changes include clear requirements for submitting documents and product lists, electronic submissions, fee adjustments, and new service agreements that outline the scope of services Swiss Medic will provide, as well as the entitlements and obligations of the companies.